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临床试验/NCT06174675
NCT06174675已完成不适用

Combined Bilateral Infraorbital and Infratrochlear Nerve Block Versus Conventional Systemic Analgesia for Patients Undergoing Nasal Surgeries

Ain Shams University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Total amount of intraoperative fentanyl

研究概览

简要总结

The aim of the study is to assess the efficacy of adding a pre-emptive combined bilateral infraorbital and infratrochlear nerve blocks with bupivacaine 0.25% in decreasing intraoperative and postoperative analgesics consumption and maintaining intraoperative hemodynamic stability during nasal surgeries.

详细描述

Perioperative pain management is one of the most important issues of most surgical procedures. The goal of every pain management technique is to reduce or eliminate pain and discomfort with minimum side effects (Garmella and Cellini, 2012).

Nasal surgical procedures are associated with a high incidence of emergence agitation leading to severe complications such as bleeding and delayed recovery which increase the hospital stay (Kim et al., 2015).

Although the cause of emergence agitation is not well established, Pain in the immediate post-operative period is one of the significant risk factors for emergence agitation. Multiple analgesic interventions are applied to the patient before, during and after surgery prevent these complications (Gray et al., 2018).

The most utilized analgesic interventions are combinations of narcotic and non-steroidal anti-inflammatory drugs. However, they are associated with gastrointestinal and neurological side effects which cause discomfort to the patient and affect surgical recovery profile (Çelik et al., 2018). Therefore, the utility of combining regional nerve block with general anesthesia has been popularized in clinical practice to provide improved perioperative analgesia, decreased narcotic consumption and enhanced emergence and recovery characteristics (Mariano et al., 2009; Ibrahim et al., 2018).

The infraorbital nerve (ION) is a branch of the maxillary part of the trigeminal nerve. This nerve innervates the skin of the nose and septum mobile nasi. The infratrochlear nerve (ITN) innervates the root of the nose and is an extraconal branch of the nasociliary nerve, which is a branch of the ophthalmic portion of the trigeminal nerve (Choi et al., 2019).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group: 18 - 55 years old.
  • American Society of Anesthesiologists (ASA) Physical Status Class I or II
  • Scheduled for elective nasal surgery under general anesthesia.

排除标准

  • Refusing to participate in the study or inability to provide informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy, INR ≥ 1.4 and local infection).
  • Compromised renal or liver functions.
  • History of substance or alcohol abuse.
  • Pre-existing chronic pain of different etiology.
  • Psychiatric disorders.

结局指标

主要结局

Total amount of intraoperative fentanyl

时间窗: throughout the surgery

次要结局

  • The time from induction of anesthesia to the first additional dose of fentanyl intraoperative.(throughout the surgery)
  • 1. Hemodynamic changes(every 15 minutes during the surgery, upon arrival to the PACU and after 30 min.)
  • Any complications related to the nerve block such as injection site pain, edema, hematoma or neurological deficits in the blocked area such as paresthesia or prolonged paralysis of the upper lip.(24 hours postoperatively)
  • Number of patients needed rescue analgesia intraoperative or postoperative.(throughout the surgery and 24 hours postoperatively)
  • Total amount of postoperative pethidine given(24 hours postoperatively)
  • Postoperative side effects such as nausea, vomiting and headache.(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayat Mohamed Elshaer

assistant lecturer of anesthesia

Ain Shams University

研究点 (2)

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